§ 5.76 - Certification of antibiotic drugs.

Related Notices

Latest version.

The following officials are authorized to certify or reject batches of antibiotic drugs, or any derivative of these drugs, pursuant to sections 507(a) and 512(n) of the Federal Food, Drug, and Cosmetic Act:

(a) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

(b) The Director and Deputy Director, Office of Compliance, CDER.

(c) The Director and Deputy Director, Division of Prescription Drug Compliance and Surveillance, Office of Compliance, CDER.

(d) The Team Leader and Assistant, Post-Marketing Surveillance Team, Division of Prescription Drug Compliance and Surveillance, Office of Compliance, CDER.

                    
                        var val = document.getElementById('citecontent').innerHTML;
                        art.dialog.defaults.title = window.location.href;
                        art.dialog.data('cite', val);
                        art.dialog.data('homeDemoPath', '/Scripts/plus/artDialog/');
                        art.dialog.open('/Scripts/plus/artDialog/citeiframe.html');